Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT03601000|
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Dysfunction||Drug: Yi-Zhi-An-Shen Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-blind, placebo-controlled study.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Study|
|Actual Study Start Date :||April 21, 2018|
|Actual Primary Completion Date :||April 30, 2019|
|Actual Study Completion Date :||September 12, 2019|
Yi-Zhi-An-Shen Granules given three times every day for 16 weeks.
Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.
Placebo Comparator: Placebo
Placebo given three times every day for 16 weeks.
Placebo granules 5g given three times a day for up to 16 weeks.
- Change from Baseline in Alzheimer´s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score [ Time Frame: Baseline, 16 weeks, 22 months ]The ADAS-Cog was developed as an outcome measure for global cognition in clinical trials. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation, for a total of 70 points (0: no cognitive impairment; 70: severe impairment). An improvement of 4 points is used as a criterion of clinically effective anti-dementia drugs.
- Change from Baseline in the Mini Mental Status Examination (MMSE) [ Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months ]Changes in the global cognitive function will be accessed by MMSE to evaluate the severity of subjects' cognitive impairment. The MMSE includes orientation, registration, attention and calculation, recalling and language tests, for a total of 30 points. A score below 24 is considered abnormal for dementia screening.
- Change from Baseline in the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months ]MoCA (Changsha Version), as a assessment tool for rapid MCI screening, will be used to assess changes in the global cognitive function. With a total of 30 points, a score below 25 is considered abnormal, and the lower score indicates the worse cognition.
- Change from Baseline in the Clinical Dementia Rating Scale (CDR) [ Time Frame: Baseline, 16 weeks, 22 months ]The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD and related dementias: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. Scores on the CDR range from 0 (no impairment) to 3 (severe impairment). The total CDR ratings for each of the six cognitive/functional domains can be added to create a CDR sum of boxes (CDR-SB).
- Change from Baseline in the Activity of Daily Living (ADL) [ Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months ]ADLs will be assessed including basic activities of daily living (BADL) and instrumental activities of daily living (IADL). An individual's BADL will be evaluated mainly by the subjects' performance from the perspectives of bathing, dressing, grooming, initiation, toileting and feeding, with six items and a sum of scores ranging from 0 (normal) to 24 (complete dependence on others). And modified Lawton Instrumental Activities of Daily Living Scale will be used to measure the IADL of a subject, with eight items and a sum of scores ranging from 0 (normal) to 32 (complete dependence on others).
- Change from Baseline in the Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months ]The PSQI will be used to assess participants' comprehensive sleep quality, including sleep quality, sleep duration, sleep efficiency, sleep disorders, daytime dysfunction, sleeping aids, etc. The total score is 21, with a higher score indicating a worse sleep quality.
- Differences between patients with aMCI and individuals with normal cognition in gut microbiome. [ Time Frame: Baseline, 16 Weeks ]The investigators will collect some fecal samples from participants. Then, differences in gut microbiome between patients with aMCI and individuals with normal cognition will be analyzed using 16SrDNA and Metagenomics analyses. When it is available, the investigators will also assess the change in gut microbiome between the treatment group and the placebo group after the intervention of YZASG.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601000
|Teaching Hospital of Chengdu University of Traditional Chinese Medicine|
|Chengdu, Sichuan, China, 610075|
|Welfare Institution of Emei Civil Administration|
|Leshan, Sichuan, China|
|Principal Investigator:||Wenbin Wu||Chengdu University of Traditional Chinese Medicine|